Device recall
Z-1543-2020: Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1543-2020 |
|---|---|
| Recall event | 85073 |
| Product | Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system. |
| Product code | MBF |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2022 |
| 510(k) numbers | K060692 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database